This trial is active, not recruiting.

Condition hodgkin lymphoma
Sponsor Ospedale Santa Croce-Carle Cuneo
Start date January 2006
End date November 2014
Trial size 160 participants
Trial identifier NCT00877747, HD-PET-intens-retr


Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown.

From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD
Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP

Primary Outcomes

Progression Free Survival
time frame: 2 years

Secondary Outcomes

Incidence of progression/relapse
time frame: 2 years
Interim PET positive and negative predictive value
time frame: 2 years

Eligibility Criteria

Male or female participants from 16 years up to 80 years old.

Inclusion Criteria: - Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification - Age 16-80 - Not previously treated - Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion) - Written informed consent Exclusion Criteria: - Patients aged more than 80 - Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma - Psychiatric disorders - Uncontrolled infectious disease - Impaired cardiac (EF < 50%) or renal (creatinine clearance < 60 ml/m)function - Pregnancy and lactation - Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl

Additional Information

Official title Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study
Principal investigator Andrea Gallamini, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ospedale Santa Croce-Carle Cuneo.